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NCT04753775 Clinical Trial

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.

Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC) Clinical Trial

Official title:
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04753775
Other study ID # Rif. 1836/11.03.10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 10, 2010
Est. completion date May 10, 2010

Study information
Verified date February 2021
Source Ospedale Sandro Pertini, Roma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aloe vera is used for the treatment of inflammatory bowel disease (IBD), but no data are present in regard the gel formulation as topical therapy in active ulcerative colitis.

Description:

44 ulcerative colitis (UC) patients were enrolled and randomly allocated to treatment for 4 weeks with oral mesalazine (800 mg three times daily) and enema (60 ml aloe vera gel) 1/day (n = 22, Group A) or enema (60 ml placebo) (n = 22, Group B).

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date May 10, 2010
Est. primary completion date April 10, 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age over 18 years, mild to moderate active ulcerative proctosigmoiditis, diagnosed for the first time and no therapy started before. The maximum extension of the disease was accepted of 40-60 cm from the anal verge or distal disease. Exclusion Criteria: - an extension of disease above the sigma, renal impairment, pregnancy, lactation or established low compliance

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Aloe vera gel

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ospedale Sandro Pertini, Roma

Outcome
Type Measure Description Time frame Safety issue
Primary endoscopic remission 4 weeks